Latest news with #UnitedTherapeutics'
Business Insider
26-05-2025
- Business
- Business Insider
Liquidia price target raised to $25 from $22 at BofA
BofA raised the firm's price target on Liquidia (LQDA) to $25 from $22 and keeps a Buy rating on the shares. The company's Yutrepia was approved as a 505b2 alternative to United Therapeutics' (UTHR) Tyvaso, the analyst tells investors in a research note. The firm says the Yutrepia label is highly similar Tyvaso, given the 505b2 nature of the regulatory program. BofA finds Liquidia shares undervalued relative to the peak sales opportunity. Confident Investing Starts Here:
Yahoo
15-05-2025
- Business
- Yahoo
Stewartville pig-to-human transplant facility to be complete in 2026
May 14—STEWARTVILLE, Minn. — A very different kind of "hog farm" is being built by United Therapeutics Corp. on the edge of Stewartville to raise gene-edited pigs in a $110 million pathogen-free facility to harvest kidneys and hearts for transplantation into humans. Maryland-based United Therapeutics, a $14 billion pharmaceutical and biotech firm, paid $4.5 million to buy 32 acres in the Schumann Business Park in August 2024. Construction of the new 65,000-square-foot complex is moving quickly. United Therapeutics has two types of pigs that have been altered at the genetic-level to make their hearts and kidneys less likely to be rejected when transplanted into a human. UT's Head of Investor & Media Relations Dewey Steadman recently visited the site to "make sure that our neighbors know what we're doing." He explained that the plan is to complete the construction and introduce the first pigs in 2026. Once the first pigs are born inside the facility, the site will be commissioned in 2027 and start producing up to 125 organs — kidneys and hearts — for human transplantation. The Stewartville project is moving forward just as many aspects of UT's pig-to-human transplant efforts are gaining traction. It conducted the first successful pig-to-human heart transplant in 2022 and the first pig-to-human kidney transplant in 2024. In February, the U.S. Food and Drug Administration approved a clinical trial of United Therapeutics' "UKidney," which is derived from a 10 gene-edited source pig. The first transplant in this trial is expected to be performed around mid-2025. The 10 gene-edited animals at the Stewartville facility will produce "UKidneys" and "UHearts" and pigs with one gene-edit will be the source of "UThymoKidneys." This is the first human clinical trial of a xeno-organ, though UT has applied for more trials for other of their organs. Steadman said while the research is progressing, it will take some time for xenotransplantation to be a common practice. "We hope to have this approved by the FDA by the end of the decade," he said. UT believes the need for more organs is only going to grow as the demand for organs outstrips the supply. More than 557,000 patients in the U.S. are on dialysis, according to the American Kidney Fund. United Therapeutics estimates that approximately 500,000 dialysis patients in the U.S. will not qualify for the kidney transplant list or may not be prioritized high enough on the waiting list to receive a transplant. The Stewartville facility will need about 20 employees at a base wage of $75,000 a year. The animals producing United Therapeutics' three types of gene-edited organs will live their entire lives in the sterile environment. Dewey said the facility has the capacity to house up to 200 of the special pigs. The Stewartville complex will be a twin of UT's pathogen-free facility in Christianburg, Virginia, which opened in March 2024. Steadman explained why UT chose to build in Stewartville. "Stewartville checked a number of boxes for us. The town of Stewartville has been extremely cooperative and excited about working with us," he said. "... The proximity of Mayo Clinic, I-90 and the (Rochester International) Airport were all factors." Organs for transplanting have an ideal window of 10 to 12 hours, so access to transportation is crucial. The unique combination of a skilled medical and agricultural workforce also made Stewartville attractive. While swine are at the heart of this project, Steadman added that people in the area should not be concerned that the UT facility will smell like a traditional pig farm. "The air that goes into the pigs will be filtered and the air that comes out will be completely filtered, too. You won't know that pigs are in the facility," he said. "This is a very high-tech pharmaceutical plant first, and then a pig farm second." While Mayo Clinic is not currently involved with the xenotransplantation operation, UT and Mayo Clinic do work together on human lung transplants in Florida. The company's CEO and founder Dr. Martine Rothblatt is also a member of Mayo Clinic's Board of Trustees. Rothblatt is a medical ethicist, an inventor, an attorney and a pilot. Rothblatt, who co-founded Sirius Satellite Radio, created United Therapeutics in 1996 to find a cure for her daughter's medical condition — pulmonary arterial hypertension.
Yahoo
14-05-2025
- Business
- Yahoo
UTHR Q1 Earnings Call: Double-Digit Growth Continues, Pipeline Expansion Remains Central
Biotechnology company United Therapeutics (NASDAQ:UTHR) reported Q1 CY2025 results exceeding the market's revenue expectations , with sales up 17.2% year on year to $794.4 million. Its non-GAAP profit of $7.28 per share was 11.3% above analysts' consensus estimates. Is now the time to buy UTHR? Find out in our full research report (it's free). Revenue: $794.4 million vs analyst estimates of $752.6 million (17.2% year-on-year growth, 5.6% beat) Adjusted EPS: $7.28 vs analyst estimates of $6.54 (11.3% beat) Adjusted EBITDA: $420.2 million vs analyst estimates of $379 million (52.9% margin, 10.9% beat) Operating Margin: 48.2%, down from 52.6% in the same quarter last year Free Cash Flow Margin: 50.4%, similar to the same quarter last year Market Capitalization: $13.88 billion United Therapeutics reported a first-quarter performance driven by sustained demand for its treprostinil-based therapies, including Tyvaso, Orenitram, and Remodulin. Management attributed the quarter's revenue growth to increased patient referrals and deeper engagement among healthcare providers, particularly within the pulmonary hypertension field. President Michael Benkowitz emphasized, 'We continue to see very strong referrals, starts and patient shipments for all of our treprostinil products.' Looking ahead, United Therapeutics' leadership highlighted a robust late-stage pipeline, ongoing regulatory milestones, and the company's disciplined approach to capital allocation as key factors in its guidance. CEO Dr. Martine Rothblatt outlined expectations for further expansion into new indications and organ transplantation programs, noting, 'We have entered a sustained period of clinical and regulatory events poised to propel our business forward.' Management also reiterated confidence in maintaining double-digit growth, citing upcoming data readouts and planned product launches. Management pointed to broad-based commercial momentum and disciplined investment as the main drivers of first-quarter results, while emphasizing the strategic importance of pipeline development and manufacturing expansion. Treprostinil Product Expansion: Growth was fueled by strong demand for Tyvaso (including both DPI and nebulizer forms), Orenitram, and Remodulin, with a notable increase in both prescriber base and depth of prescribing. Management stated that treprostinil therapies remain central to pulmonary hypertension treatment despite new market entrants. Tyvaso DPI Uptake: Tyvaso DPI (dry powder inhaler) continued gaining share, with new patient starts stabilizing at roughly two-thirds DPI versus one-third nebulizer. Leadership underscored device convenience and dosing flexibility as differentiators supporting sustained uptake. Pricing and Payer Environment: A routine price increase for Tyvaso and Orenitram contributed to revenue, while the impact from Medicare Part D redesign was described as modest and largely offset by manufacturer obligations under the new structure. Pipeline and R&D Progress: Five registration-phase clinical studies are underway, including the TETON trials in idiopathic pulmonary fibrosis and new organ transplantation programs. The company reported positive regulatory feedback on its UTHYMOKIDNEY and UHeart programs, enabling advancement without further animal studies. Manufacturing and Capital Allocation: Ongoing investments include expansion of Tyvaso DPI manufacturing capacity and the commissioning of specialized facilities for organ development. Management highlighted its balanced capital deployment across R&D, corporate development (including the IVIVA and Miromatrix acquisitions), and shareholder returns. Management's outlook for the coming quarters centers on expanding existing product indications, advancing late-stage pipeline programs, and maintaining operational efficiency amid a competitive landscape. Pipeline Readouts and Indications: Upcoming data from the TETON trials in idiopathic pulmonary fibrosis could enable label expansion for Tyvaso, opening access to a larger patient population and driving future revenue. Transplantation Programs: Progress in xenotransplantation, including the planned EXPAND study for genetically engineered kidneys and potential IND filings for UTHYMOKIDNEY and UHeart, may add long-term growth avenues if clinical milestones are met. Competitive and Regulatory Risks: Management acknowledged the increasingly competitive pulmonary arterial hypertension market and evolving payer requirements, but expressed confidence that product differentiation and ongoing R&D investment would preserve growth. Joseph Thome (TD Cowen): Asked about patient selection and learnings from the recent UTHYMOKIDNEY case, including how immunosuppression adjustments informed future trials. Dr. Leigh Peterson explained that future protocols would apply insights from the previous participant, particularly around infection management and immunosuppression. Jessica Fye (JPMorgan): Sought clarity on the revenue impact from the Medicare Part D redesign. President Michael Benkowitz replied that the net benefit this quarter was modest, as additional manufacturer obligations largely offset patient out-of-pocket reductions. Roanna Ruiz (Leerink Partners): Questioned the drivers of Tyvaso DPI growth and any effects from gross-to-net adjustments. Benkowitz indicated that growth was mainly due to patient demand and prescriber adoption, with price changes and gross-to-net impacts minimal in the quarter. Andreas Argyrides (Oppenheimer): Inquired about capital allocation priorities and the potential for further share repurchases or acquisitions. CFO James Edgemond stated that internal R&D, manufacturing, and targeted M&A remain top priorities, with share repurchases considered based on available opportunities. Ash Verma (UBS): Asked about patient volume trends for Tyvaso and competitive positioning versus upcoming products. Benkowitz declined to provide specific patient add figures but noted that revenue trends closely mirror demand, and management remains confident in Tyvaso's market position. In the coming quarters, the StockStory team will be monitoring (1) key clinical milestones such as data readouts from the TETON trials and initial xenotransplantation procedures, (2) the pace of Tyvaso DPI adoption and deeper market penetration, and (3) developments in the competitive pulmonary hypertension landscape. Progress on pipeline programs and the company's ability to navigate regulatory or pricing changes will also be important factors. United Therapeutics currently trades at a forward P/E ratio of 10.5×. Is the company at an inflection point that warrants a buy or sell? See for yourself in our free research report. The market surged in 2024 and reached record highs after Donald Trump's presidential victory in November, but questions about new economic policies are adding much uncertainty for 2025. While the crowd speculates what might happen next, we're homing in on the companies that can succeed regardless of the political or macroeconomic environment. Put yourself in the driver's seat and build a durable portfolio by checking out our Top 6 Stocks for this week. This is a curated list of our High Quality stocks that have generated a market-beating return of 176% over the last five years. Stocks that made our list in 2020 include now familiar names such as Nvidia (+1,545% between March 2020 and March 2025) as well as under-the-radar businesses like the once-micro-cap company Kadant (+351% five-year return). Find your next big winner with StockStory today. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
